HIV Infections Clinical Trial
Official title:
Solid Organ Transplantation in HIV: Multi-Site Study
Verified date | January 2014 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
With improved anti-HIV drug therapy, HIV infected patients are now living longer. These patients are at risk for liver and kidney failure and may need organ transplants. However, little is know about the safety and effectiveness of organ transplants in patients with HIV. This study will evaluate organ transplantation in HIV infected patients undergoing liver and kidney transplants.
Status | Completed |
Enrollment | 275 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year and older |
Eligibility |
Inclusion Criteria for All Participants: - HIV infection - Undetectable HIV viral load - Meet all eligibility requirements for a transplant (same requirements that HIV uninfected patients must meet) - Willing to take medication to prevent certain infections - Willing to undergo frequent monitoring, including liver biopsies, and treatment, if participant has hepatitis B or C virus infection - Willing to submit laboratory test results within 7 days of blood draw - Willing to notify the transplant team before changing any medications - If participant has a history of HIV-related cancers or opportunistic infections, some additional eligibility criteria must be met. Inclusion Criteria for Patients Undergoing Kidney Transplant: - CD4 count greater than 200 cells/mm3. CD4 count requirement for children will be based on child's age. Participant cannot have used the drugs IL-2 or GM-CSF in order to increase the CD4 count in the 6 months prior to transplant. Inclusion Criteria for Patients Undergoing Liver Transplant: - CD4 count greater than 100 cells/mm3. CD4 count requirement for children will be based on child's age. Some participants with certain HIV-related diseases must have a CD4 count that is greater than 200 cells/ml for the 6 months prior to study entry. Exclusion Criteria for All Participants: - Pregnancy - Significant wasting or weight loss |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Maryland | Baltimore | Maryland |
United States | Beth Israel Deaconess | Boston | Massachusetts |
United States | University of Virginia | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | The University Hospital, Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Cedar-Sinai Hospital | Los Angeles | California |
United States | University of Miami, Jackson Memorial Medical Center | Miami | Florida |
United States | Tulane University | New Orleans | Louisiana |
United States | Columbia Presbyterian Hospital | New York | New York |
United States | Mt. Sinai Medical Center | New York | New York |
United States | Drexel University College of Medicine | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh, Thomas E. Starzl Institute | Pittsburgh | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
United States | Georgetown University | Washington | District of Columbia |
United States | Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Ansari IU, Allen T, Berical A, Stock PG, Barin B, Striker R. Phenotypic analysis of NS5A variant from liver transplant patient with increased cyclosporine susceptibility. Virology. 2013 Feb 20;436(2):268-73. doi: 10.1016/j.virol.2012.11.018. Epub 2013 Jan — View Citation
Bahirwani R, Barin B, Olthoff K, Stock P, Murphy B, Rajender Reddy K; Solid Organ Transplantation in HIV: Multi-Site Study Investigators. Chronic kidney disease after liver transplantation in human immunodeficiency virus/hepatitis C virus-coinfected recip — View Citation
Bihl FK, Loggi E, Chisholm JV 3rd, Hewitt HS, Henry LM, Linde C, Suscovich TJ, Wong JT, Frahm N, Andreone P, Brander C. Simultaneous assessment of cytotoxic T lymphocyte responses against multiple viral infections by combined usage of optimal epitope matr — View Citation
Carter JT, Melcher ML, Carlson LL, Roland ME, Stock PG. Thymoglobulin-associated Cd4+ T-cell depletion and infection risk in HIV-infected renal transplant recipients. Am J Transplant. 2006 Apr;6(4):753-60. — View Citation
Chin-Hong P, Beatty G, Stock P. Perspectives on liver and kidney transplantation in the human immunodeficiency virus-infected patient. Infect Dis Clin North Am. 2013 Jun;27(2):459-71. doi: 10.1016/j.idc.2013.02.010. Epub 2013 Mar 29. Review. — View Citation
Coffin CS, Stock PG, Dove LM, Berg CL, Nissen NN, Curry MP, Ragni M, Regenstein FG, Sherman KE, Roland ME, Terrault NA. Virologic and clinical outcomes of hepatitis B virus infection in HIV-HBV coinfected transplant recipients. Am J Transplant. 2010 May;1 — View Citation
Frassetto L, Baluom M, Jacobsen W, Christians U, Roland ME, Stock PG, Carlson L, Benet LZ. Cyclosporine pharmacokinetics and dosing modifications in human immunodeficiency virus-infected liver and kidney transplant recipients. Transplantation. 2005 Jul 15 — View Citation
Frassetto L, Floren L, Barin B, Browne M, Wolfe A, Roland M, Stock P, Carlson L, Christians U, Benet L. Changes in clearance, volume and bioavailability of immunosuppressants when given with HAART in HIV-1 infected liver and kidney transplant recipients. — View Citation
Frassetto LA, Browne M, Cheng A, Wolfe AR, Roland ME, Stock PG, Carlson L, Benet LZ. Immunosuppressant pharmacokinetics and dosing modifications in HIV-1 infected liver and kidney transplant recipients. Am J Transplant. 2007 Dec;7(12):2816-20. Epub 2007 O — View Citation
Frassetto LA, Tan-Tam C, Stock PG. Renal transplantation in patients with HIV. Nat Rev Nephrol. 2009 Oct;5(10):582-9. doi: 10.1038/nrneph.2009.140. Review. — View Citation
Gasser O, Bihl F, Sanghavi S, Rinaldo C, Rowe D, Hess C, Stablein D, Roland M, Stock P, Brander C. Treatment-dependent loss of polyfunctional CD8+ T-cell responses in HIV-infected kidney transplant recipients is associated with herpesvirus reactivation. A — View Citation
Gregg KS, Barin B, Pitrak D, Ramaprasad C, Pursell K. Acquired hypogammaglobulinemia in HIV-positive subjects after liver transplantation. Transpl Infect Dis. 2013 Dec;15(6):581-7. doi: 10.1111/tid.12139. Epub 2013 Sep 18. — View Citation
Harbell J, Fung J, Nissen N, Olthoff K, Florman SS, Hanto DW, Light J, Bartlett ST, Tzakis AG, Pearson TC, Barin B, Roland ME, Stock PG; HIV-TR Investigators. Surgical complications in 275 HIV-infected liver and/or kidney transplantation recipients. Surge — View Citation
Nissen NN, Barin B, Stock PG. Malignancy in the HIV-infected patients undergoing liver and kidney transplantation. Curr Opin Oncol. 2012 Sep;24(5):517-21. doi: 10.1097/CCO.0b013e328355e0d7. Review. — View Citation
Ragni MV, Devera ME, Roland ME, Wong M, Stosor V, Sherman KE, Hardy D, Blumberg E, Fung J, Barin B, Stablein D, Stock PG. Liver transplant outcomes in HIV+ haemophilic men. Haemophilia. 2013 Jan;19(1):134-40. doi: 10.1111/j.1365-2516.2012.02905.x. Epub 20 — View Citation
Roland ME, Carlson LL, Frassetto LA, Stock PG. Solid organ transplantation: referral, management, and outcomes in HIV-infected patients. AIDS Read. 2006 Dec;16(12):664-8, 675-8. Review. — View Citation
Roland ME, Stock PG. Liver transplantation in HIV-infected recipients. Semin Liver Dis. 2006 Aug;26(3):273-84. Review. — View Citation
Roland ME, Stock PG. Solid organ transplantation is a reality for patients with HIV infection. Curr HIV/AIDS Rep. 2006 Sep;3(3):132-8. Review. — View Citation
Stock PG, Barin B, Murphy B, Hanto D, Diego JM, Light J, Davis C, Blumberg E, Simon D, Subramanian A, Millis JM, Lyon GM, Brayman K, Slakey D, Shapiro R, Melancon J, Jacobson JM, Stosor V, Olson JL, Stablein DM, Roland ME. Outcomes of kidney transplantati — View Citation
Stock PG, Roland ME. Evolving clinical strategies for transplantation in the HIV-positive recipient. Transplantation. 2007 Sep 15;84(5):563-71. — View Citation
Subramanian A, Sulkowski M, Barin B, Stablein D, Curry M, Nissen N, Dove L, Roland M, Florman S, Blumberg E, Stosor V, Jayaweera DT, Huprikar S, Fung J, Pruett T, Stock P, Ragni M. MELD score is an important predictor of pretransplantation mortality in HI — View Citation
Tan-Tam CC, Frassetto LA, Stock PG. Liver and kidney transplantation in HIV-infected patients. AIDS Rev. 2009 Oct-Dec;11(4):190-204. Review. — View Citation
Terrault NA, Carter JT, Carlson L, Roland ME, Stock PG. Outcome of patients with hepatitis B virus and human immunodeficiency virus infections referred for liver transplantation. Liver Transpl. 2006 May;12(5):801-7. — View Citation
Terrault NA, Roland ME, Schiano T, Dove L, Wong MT, Poordad F, Ragni MV, Barin B, Simon D, Olthoff KM, Johnson L, Stosor V, Jayaweera D, Fung J, Sherman KE, Subramanian A, Millis JM, Slakey D, Berg CL, Carlson L, Ferrell L, Stablein DM, Odim J, Fox L, Stock PG; Solid Organ Transplantation in HIV: Multi-Site Study Investigators. Outcomes of liver transplant recipients with hepatitis C and human immunodeficiency virus coinfection. Liver Transpl. 2012 Jun;18(6):716-26. doi: 10.1002/lt.23411. — View Citation
* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subject survival | 5 years | Yes | |
Primary | graft survival | 5 years | Yes | |
Secondary | Opportunistic complications | 5 years | Yes | |
Secondary | CD4+ T cell counts and HIV-1 RNA levels | 5 years | Yes | |
Secondary | viral markers and host-response (CFC and ELISPOT) to viral co-pathogens, including HBV, HCV,CMV, EBV, HHV-6, HHV-8, and HPV | 5 years | Yes | |
Secondary | rejection rates and markers of alloresponse | 5 years | Yes | |
Secondary | pharmacokinetic interactions between immunosuppressive agents and antiretrovirals | 5 years | Yes |
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